We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (DG002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01031524
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : December 14, 2009
Information provided by:

Study Description
Brief Summary:
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Biological: PfCS102 Biological: Montanide ISA 720 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Double-blind Controlled Phase I/IIa Trial to Assess the Efficacy of Malaria Vaccine PfCS 102 (282-383) to Protect Against Artificial Challenge With P. Falciparum
Study Start Date : March 2004
Primary Completion Date : July 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: vaccine
30 µg of PfCS102 formulated in Montanide ISA 720
Biological: PfCS102
Antigen of the sporozoite protein
Placebo Comparator: adjuvant
Montanide ISA 720
Biological: Montanide ISA 720
adjuvant alone

Outcome Measures

Primary Outcome Measures :
  1. Length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy [ Time Frame: 1month ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • resident in or near Lausanne;
  • age >18 and <45 years;
  • written informed consent;
  • >10/12 correct responses to the questionnaire of understanding.

Exclusion Criteria:

  • history of malaria; possible exposure to malaria within the previous 6 months;
  • positive serology for PfCS102by ELISA;
  • history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
  • pregnant or lactating female;
  • any confirmed or suspected immunodeficient condition;
  • seropostivity for HIV;
  • chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease;
  • hemoglobinopathies;
  • history of >2 hospitalisations for invasive bacterial infections;
  • requirement of any chronic medication;
  • suspected or known current alcohol or illegal drug abuse (excluding cannabis);
  • any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study;
  • a body mass index < 18kg/m2 or > 32 kg/m2;
  • evidence of past or present psychiatric condition;
  • seropositivity for HIV, hepatitis C or B (other than HBs Ab);
  • 10-year risk of coronary heart disease <10%;
  • any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031524

Department of Ambulatory Care and Community Medicine; University Hospital
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Centre Hospitalier Universitaire Vaudois
Radboud University
Principal Investigator: Blaise Genton, MD PhD University Hospital
More Information

Responsible Party: Blaise Genton, Department of Ambulatory care and Community Medicine, University of Lausanne
ClinicalTrials.gov Identifier: NCT01031524     History of Changes
Other Study ID Numbers: 09/04
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: December 14, 2009
Last Verified: December 2009

Keywords provided by Swiss Tropical & Public Health Institute:
Plasmodium falciparum malaria

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diuretics, Osmotic
Natriuretic Agents